Senior Manager, Regulatory Affairs US Lead

Location:

Seaport, Boston or Gaithersburg, Maryland

Reports to:

Senior Director, Global Regulatory Strategy About Alexion For over 30 years, Alexion has been dedicated to transforming the lives of people living with rare diseases. We lead with breakthrough science, deep disease understanding, and a dedicated commitment to patients. As part of AstraZeneca, we are uniquely positioned to accelerate innovation and reach more patients globally. Working here means being driven by purpose, acting with integrity, and fostering a culture where people feel valued, connected, and empowered.

You'll join a community that puts patients first, plays to win, and supports your development at every step.

Role Overview :

The Senior Manager, Regulatory Affairs US lead will be responsible for leading, planning, preparing and delivering regulatory strategies and activities for assigned product(s)/project(s) across the assigned jurisdiction supporting global regulatory strategies, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.

This individual will provide tactical and strategic regulatory input and leadership across regulatory and cross-functional teams, teams with the objective of delivering according to regional and global Business Objectives. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

Key Responsibilities:

Accountable as US Regulatory Lead to develop and implement regulatory strategies for assigned project(s)/product(s) in the US and accountable to provide regulatory advice to cross-functional strategies and associated deliverables according to business objectives.

Responsible for the management and execution of regulatory submissions in the US (e.g. INDs, BLAs/NDAs, orphan drug designation applications, pediatric submissions, etc.), by actively collaborating with other Regulatory functions and cross-functional teams to deliver business objectives for assigned products/programs..Represents Alexion as point of contact with the US FDA or other relevant external partners, including the planning and management of regulatory authority meetings, in alignment with global regulatory and cross-functional strategy.

Responsible for overseeing operational activities related to the Regulatory authorizations according to current regulatory internal and external requirements for the assigned jurisdiction(s).Supports the Global Regulatory Lead in internal Governance and advisory bodies, or other relevant internal activities, including the development and management of select Regulatory processes and procedures, as well as inspection/audit support.

Actively collaborates with other Regulatory teams and Enterprise functions (e.g. Commercial, Medical) to provide regulatory input to business-relevant deliverables concerning assigned project/product and jurisdiction.

Actively be up to date on and efficiently apply latest regulatory requirements and trends, within assigned jurisdiction and regulatory focus area (e.g. clinical development, lifecycle management).Ensure exemplary behavior, leadership, ethics and visibility within the Enterprise, with Health Authorities and other external partners.

You will need to have:

Qualifications & Education6+ years of relevant Regulatory experience in the pharmaceutical industry, with experience in US regional regulatory strategies.

Bachelor’s degree in life science required; relevant postgraduate degree (e.g., MSc, PharmD, or PhD) is preferred.

Experience providing strategic regulatory advice in relevant regulatory jurisdiction(s) (e.g., US)…